drugset / Trial / NCT02752763

Comparison of Autologous Serum Versus Preservative Free Artificial Tear

NCT02752763

Phase 4 Completed 24 enrolled Niğde State Hospital
RandomizedCrossoverDouble-blindTreatment

Summary

Dry eye is a significant adverse effect of isotretinoin causing patients to use ophthalmic medications. For this reason, many patients using isotretinoin are referred to ophthalmology clinic because of discomfort symptoms. In the literature, there are studies suggesting superiority of Autologous serum drops regarding effects on ocular surface when compared to artificial tear. In addition, Autologous serum was also used in several corneal pathologies with successful outcomes. No data regarding use in the ocular adverse effects of isotretinoin was found in the literature; however, investigators think that it may be an effective alternative in the treatment of dry eye developed during isotretinoin use due to positive effects on ocular surface, epithelial regeneration and anti-inflammatory effect. Autologous serum can be a choice of ophthalmologists in routine practice by increasing number of comprehensive studies investigating effectiveness, safety and long-terms effects of Autologous serum therapy.In this study, it was aimed to investigate dry eye development in the patients receiving systemic retinoic acid therapy and to compare effectiveness of Autologous serum and Preservative free artificial tear in the patients with dry eye disease.

Timeline

Start
2015-10
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous serum Unknown 1 unknown Other
Subject Carboxymethylcellulose Other / unclassified 1 unknown Other
Subject Polyvinyl alcohol Unknown 1 unknown Other
Subject Povidone Unknown 1 unknown Other
Subject hydroxypropylmethylcellulose Unknown 1 unknown Other

Indications